Fluvastatin and Perioperative Events in Patients Undergoing Vascular Surgery.
Fluvastatin and Perioperative Events in Patients Undergoing Vascular Surgery.
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DOI：
10.1056/nejmoa0808207
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发表时间：
2009-09-03
影响因子：
158.5
通讯作者：
Poldermans, Don
中科院分区：
文献类型：
--
作者：
Schouten, Olaf;Boersma, Eric;Poldermans, Don
背景：血管手术后常见的不良心脏事件。我们假设围手术期他汀类药物治疗将改善术后结果。方法：在这项双盲、安慰剂对照试验中，我们随机分配了以前没有接受过他汀类药物治疗的患者，在接受血管手术前，除服用β-受体阻滞剂外，还每天接受一次80毫克的氟伐他汀缓释剂或安慰剂。在随机分组时和手术前测量血脂、白介素6和C反应蛋白水平。主要终点是发生心肌缺血，定义为术后30天内短暂的心电图异常，肌钙蛋白T的释放，或两者兼而有之。次要终点是心血管原因死亡和心肌梗死。结果：共有250名患者服用氟伐他汀，247名服用安慰剂，血管手术前的中位数为37天。氟伐他汀组总胆固醇、低密度脂蛋白胆固醇、白介素6和C反应蛋白水平显著降低，而安慰剂组则无明显变化。术后发生心肌缺血，氟伐他汀组27例(10.8%)，安慰剂组47例(19.0%)(危险比0.55；95%可信区间0.34~0.88；P=0.01)。氟伐他汀组有12例患者(4.8%)死于心血管原因或心肌梗死，安慰剂组有25例患者(10.1%)死亡(风险比0.47；95%可信区间0.24至0.94；P=0.03)。结论：在接受血管手术的患者中，围手术期的氟伐他汀治疗与术后心脏结局的改善有关。(当前对照试验编号，ISRCTN83738615。)N Engl J Med 2009；361：980-9。
Background: Adverse cardiac events are common after vascular surgery. We hypothesized that perioperative statin therapy would improve postoperative outcomes.Methods: In this double-blind, placebo-controlled trial, we randomly assigned patients who had not previously been treated with a statin to receive, in addition to a beta-blocker, either 80 mg of extended-release fluvastatin or placebo once daily before undergoing vascular surgery. Lipid, interleukin-6, and C-reactive protein levels were measured at the time of randomization and before surgery. The primary end point was the occurrence of myocardial ischemia, defined as transient electrocardiographic abnormalities, release of troponin T, or both, within 30 days after surgery. The secondary end point was the composite of death from cardiovascular causes and myocardial infarction.Results: A total of 250 patients were assigned to fluvastatin, and 247 to placebo, a median of 37 days before vascular surgery. Levels of total cholesterol, low-density lipoprotein cholesterol, interleukin-6, and C-reactive protein were significantly decreased in the fluvastatin group but were unchanged in the placebo group. Postoperative myocardial ischemia occurred in 27 patients (10.8%) in the fluvastatin group and in 47 (19.0%) in the placebo group (hazard ratio, 0.55; 95% confidence interval [CI], 0.34 to 0.88; P=0.01). Death from cardiovascular causes or myocardial infarction occurred in 12 patients (4.8%) in the fluvastatin group and 25 patients (10.1%) in the placebo group (hazard ratio, 0.47; 95% CI, 0.24 to 0.94; P=0.03). Fluvastatin therapy was not associated with a significant increase in the rate of adverse events.Conclusions: In patients undergoing vascular surgery, perioperative fluvastatin therapy was associated with an improvement in postoperative cardiac outcome. (Current Controlled Trials number, ISRCTN83738615.)N Engl J Med 2009;361:980-9.